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Autism Spectrum DisorderRUBIESNCT05093686

RUBIES in Educational Settings

A study testing RUBIES in people with Autism Spectrum Disorder and Disruptive Behavior, run by Seattle Children's Hospital at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The proposed three-year pilot randomized trial aims to test the effectiveness of the newly-redesigned paraeducator-delivered RUBI for use in Educational Settings (RUBIES) intervention compared to usual care training in reducing disruptive behavior in 80 elementary-school children with ASD. Read more about this study

Who is it for?
Ages 5 years and olderHealthy volunteers can take part
Conditions the study is for
Autism Spectrum Disorder, Disruptive Behavior
What is being tested?
RUBIES
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteUnited States
Study dates
26 Oct 2021to 31 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Paraeducators must be employed by the school district and work directly with children with ASD in the classroom at their school.
  • Students with ASD will be included if they: 1) have a documented ASD diagnosis and a Social Responsiveness Scale-2 total raw score > 70 for males and 65 for females; 2) are enrolled in a Kindergarten-5th grade general or special education classroom and participate in a general education classroom for a minimum of 4 hours/week; 3) have a participating paraeducator; 4) have a teacher-rated Aberrant Behavior Checklist-Irritability (ABC-I) subscale score >15,; and 5) have a stable educational plan and placement.

Who cannot join

  • Paraeducator is not supporting a student with autism in a general education classroom
  • Student does not have a diagnosis of ASD or elevated disruptive behavior problems

Trial locations and contacts

1 site in 1 country.

United States1 site, 1 recruiting
  • Seattle Children's Research Institute

    Seattle, Washington, 98105

    Karen Bearss, PhD, 206-987-2880, karen.bearss@seattlechildrens.org

    Recruiting

Other trials in United States

About this study

Official title: Exploring Mechanisms of Change in a Pilot Trial of the RUBI Program in Educational Settings

The proposed three-year pilot randomized trial aims to test the effectiveness of the newly-redesigned paraeducator-delivered RUBI for use in Educational Settings (RUBIES) intervention compared to usual care training in reducing disruptive behavior in 80 elementary-school children with ASD. Given the critical need to understand not just whether, but also how interventions work, this study also will examine paraeducator- and child-level mechanistic pathways of the RUBIES intervention.

Read the detailed description

Autism spectrum disorder (ASD) is a pervasive developmental disorder characterized by deficits in social communication and the presence of restricted and/or repetitive behavior, with prevalence estimates as high as 1 in 54 children in the US. Approximately 50% of children with ASD exhibit disruptive behaviors, such as tantrums, aggression, and noncompliance, a rate that is higher than neurotypical peers in the school environment. Disruptive behaviors impact meaningful engagement in academic tasks and with peers, as well as result in placement in more restrictive settings, higher use of restraint procedures, and suspension, all of which have lasting negative impacts. School-based behavioral management approaches, while effective, are time-consuming and resource-intensive, resulting in high costs and delays in intervention deployment. There is a need for a paradigm shift in the care model for disruptive behaviors in the classroom, specifically an efficient and pragmatic intervention model that builds capacity with direct care providers, which in turn streamlines the intervention process, reduces the need for intensive behavioral supports (thus lowering costs), and increases the number of children with ASD who can be served.

Over the past decade, the Research Units in Behavioral Interventions (RUBI) Autism Network developed and systematically tested a low-intensity (11-session) manualized intervention for parents of children ages 3 to 14 with ASD and co-occurring disruptive behavior. Results across three large scale trials have demonstrated that RUBI significantly reduces child disruptive behavior, and treatment recipients are highly engaged in the intervention. To date, no studies have evaluated the effectiveness of RUBI in schools, the most accessed service system for children with ASD.

With NIMH funding from the University of Washington ALACRITY Center grant (P50MH115837), RUBI content was iteratively redesigned in collaboration with elementary school stakeholders (administrators, teachers, paraeducators) for use in educational settings using the novel Discover, Design, Build, and Test Framework, which combines human-centered design and implementation science. In addition, target end-users (paraeducators) were identified as they: 1) provide direct support to children with ASD in both general and special education classrooms for the majority of the school day; and 2) often do not receive specialized training on effective behavioral management strategies designed to support the unique needs of children with ASD. The proposed three-year pilot randomized trial extends our work to test the effectiveness of the newly-redesigned RUBI for use in Educational Settings (RUBIES) intervention compared to usual care training (UCT) in reducing disruptive behavior in 80 elementary-school children with ASD. Given the critical need to understand not just whether, but also how interventions work, this study also will examine paraeducator- and child-level mechanistic pathways of the RUBIES intervention. Study aims include:

Aim 1: Examine the acceptability and feasibility of RUBIES with paraeducators supporting children with ASD and disruptive behavior in schools. We will measure RUBIES' acceptability (attendance, attrition, satisfaction) and feasibility (demonstration of successful study design) to determine whether paraeducators can successfully implement the RUBIES intervention in schools.

Aim 2: Conduct exploratory analyses of the impact of RUBIES compared to Usual Care Training (UCT) on disruptive behavior. Results will allow us to estimate the means, standard deviations and intraclass correlations of RUBIES compared to UCT on disruptive behavior outcomes, which will be essential for sample size/power calculations for a future definitive longitudinal RCT. Exploratory Hypothesis 1: At Week 24, children whose paraeducator was randomized to RUBIES will exhibit lower rates of observed and reported disruptive behavior compared to children whose paraeducator received UCT.

Aim 3: Conduct exploratory analyses on RUBIES' proposed paraeducator- and child-level mechanisms of change on child disruptive behavior. Exploratory Hypothesis 2: RUBIES will improve paraeducator-level mechanisms (gains in knowledge; use of more effective strategies) which will improve child disruptive behavior compared to UCT. Exploratory Hypothesis 3: RUBIES will improve child-level mechanisms (functional communication skills) which will improve child disruptive behavior compared to UCT.

Specifically, a three-year pilot effectiveness randomized controlled trial will be conducted with 80 paraeducators who support a child with ASD (n=80) from 40 public elementary schools. The child's primary teacher (N=80) and caregiver (N=80) also will be consented to contribute to outcome data on the child's behavior. Thus, 80 "triads" made up of a child-paraeducator-teacher will be enrolled. Data will be collected at baseline, Weeks 8, 12 and 24. Schools will be recruited in three cohorts that align with the school year (Years 1 and 2: N=15 schools, 30 paraeducators, 30 children with ASD, and 30 teachers; Year 3: N=10 schools, 20 paraeducators, 20 children with ASD, and 20 teachers).

Successful completion of the proposed study will allow for a large-scale effectiveness trial of RUBIES in public schools, which has the potential to improve the quality of life for children with ASD across the country.

Being tested
RUBIES, Usual Care Training
Keywords
autism, elementary schools, paraeducators, disruptive behavior
Medical subject headings
Autism Spectrum Disorder, Problem Behavior, Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RUBIESBehavioural

    Also called RUBI in Educational Settings

    RUBIES is an 8 module intervention that begins with foundational education on ASD (Session1), followed by introducing basic applied behavior analysis principles (Session 2). Instruction is then provided on strategies that can prevent problematic behaviors from occurring (Session 3 and 4). Reinforcement (Session 5) reviews the use of tangible and social reinforcers tools to promote new/desired behaviors while planned ignoring and functional communication training (Session 6) teaches that disruptive behavior can serve as a form of communication while ignoring disruptive communicative attempts. Sessions conclude with instruction on effective ways to deliver commands to promote compliance (Session 7) and targeting approaches to ensure positive behavior gains can maintain over time and strategies can be used across classrooms and staff (Session 8).

  • Usual Care TrainingBehavioural

    Usual Care Training is an 8 module psychoeducation program that will provide foundational information on autism spectrum disorders, including the diagnostic criteria, appropriate educational services, common interventions, and how to promote social skills in the classroom.

Study groups in NCT05093686
Study groupRoleWhat they receive
RUBIESExperimentalRUBIES provides paraeducators in training on behavioral strategies based on principles of applied behavior analysis to target student disruptive behaviors in the classroom
Receives: Behavioral: RUBIES
Usual Care TreatmentActive comparatorUsual Care Treatment provides paraeducators with foundational psychoeducation on autism spectrum disorders.
Receives: Behavioral: Usual Care Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Aberrant Behavior Checklist

    After 24 weeks of treatment, students whose paraeducator received RUBIES will show greater reduction in classroom disruptive behavior as evidenced by reduction on the Aberrant Behavior Checklist Irritability Subscale compared to students whose paraeducator received Usual Care Treatment.

    Measured: 24 Weeks

Secondary outcomes (3)
  1. Knowledge of Behavioral Principles

    After 24 weeks of treatment, students whose paraeducator received RUBIES will show greater knowledge in behavioral principles as evidenced by higher scores on the Knowledge of Behavioral Principles measure compared to students whose paraeducator received Usual Care Treatment.

    Measured: 24Weeks

  2. RUBIES fidelity

    After 24 weeks of treatment, paraeducators who received training in RUBIES will demonstrate observed higher implementation of evidence-based strategies based on applied behavior analysis compared to students whose paraeducator received Usual Care Treatment.

    Measured: 24 Weeks

  3. Student Behavior Observation

    After 24 weeks of treatment, students whose paraeducator received RUBIES will demonstrate lower observed rates of disruptive behavior in the classroom compared to students whose paraeducator received Usual Care Treatment.

    Measured: 24 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2021
  2. Study start26 Oct 2021
  3. Primary completion30 Jun 2024 (estimated)
  4. Study completion31 Jul 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Simple 1:1 random assignment will be used to assign half (n=40) of the paraeducator/teacher/child triads to remote training in RUBIES, allowing for personalized delivery and tailoring of RUBIES to the paraeducator-child dyad, and the other half (n=40 dyads) to Usual Care Training (UCT, an "Autism 101" attention control condition) over a three-year period. No greater than 10% paraeducator turnover each year is expected based on prior studies.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05093686
Sponsor's protocol ID
SCH-STUDY00003191
Acronym
RUBIES
Status last verified
May 2023
First submitted
3 Oct 2021
Last updated
8 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Bearss K, Shih W, Tagavi DM, Kuo Y, Fettig A, Locke J. A Pilot Feasibility Randomized Trial of the RUBI in Educational Settings Intervention With Paraeducators Supporting Autistic Students in Public Elementary Schools. J Autism Dev Disord. 2025 Oct 15:10.1007/s10803-025-07072-8. doi: 10.1007/s10803-025-07072-8. Online ahead of print.

    PubMed 41091357

Questions about this trial

What is this clinical trial studying?

A study testing RUBIES in people with Autism Spectrum Disorder and Disruptive Behavior, run by Seattle Children's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Karen Bearss, PhD (206-987-2880, karen.bearss@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aberrant Behavior Checklist (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05093686, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2023.

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